The Basics
What is Leflunomide?
Used alone or in combination with other medications to treat rheumatoid arthritis.
Brand names for Leflunomide
Arava
How Leflunomide is classified
Antirheumatic Agents, Immunosuppressive Agents
Leflunomide During Pregnancy
Leflunomide pregnancy category
Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Leflunomide while pregnant
Contraindicated in pregnancy. In animal reproduction studies, oral administration of leflunomide during organogenesis at a dose of 1/10 of and equivalent to the maximum recommended human dose (MRHD) based on AUC, respectively in rats and rabbits, caused teratogenicity (rats and rabbits) and embryo-lethality (rats) . Pregnancy exposure registry data are not available at this time to inform the presence or absence of drug-associated risk with the use of ARAVA during pregnancy. The background risk of major birth defects and miscarriage for the indicated populations is unknown. The background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, stop treatment with ARAVA, apprise the patient of the potential hazard to a fetus, and perform the accelerated drug elimination procedure to achieve teriflunomide concentrations of less than 0.02 mg/L (0.02 mcg/mL) .
Taking Leflunomide While Breastfeeding
What are recommendations for lactation if you're taking Leflunomide?
No information is available on the use of leflunomide during breastfeeding, so an alternate drug may be preferred, especially while nursing a newborn or preterm infant.[1][2]
Maternal / infant drug levels
No information is available on the use of leflunomide during breastfeeding, so an alternate drug may be preferred, especially while nursing a newborn or preterm infant.[1][2]
Possible effects of Leflunomide on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Leflunomide
(Rheumatoid Arthritis) Auranofin, Gold Sodium Thiomalate, Hydroxychloroquine, Infliximab, Methotrexate, Penicillamine, Sulfasalazine.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Sammaritano LR, Bermas BL. Rheumatoid arthritis medications and lactation. Curr Opin Rheumatol. 2014;26:354-60. PMID: 24614280
2. Flint J, Panchal S, Hurrell A et al. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2016;55:1693-7. PMID: 26750124
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
